Does Diaphragm Electrical Activity Monitoring Predict Extubation Success in Children?

The Potential of Diaphragm Electrical Activity Monitoring to Predict Extubation Success in Children Requiring Mechanical Ventilation Support Due to Respiratory Failure

This study aimed to record diaphragm electrical activity (Edi) during the preextubation (weaning) and postextubation periods and to analyze whether Edi monitoring could predict extubation success.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Neurally Adjusted Ventilatory Assist; Diaphragm Electrical Activity
• Intervention / Treatment: Device: Edi catheter

Detailed Description

This prospective observational study included 25 pediatric patients who were intubated due to respiratory failure in the pediatric intensive care unit of the tertiary university-affiliated Marmara University Hospital between August 2014 and July 2015. To conduct the study, we obtained informed consent from the patient's parents and ethical approval from the Marmara University Faculty of Medicine Scientific Research Ethics Committee Board on 06.09.2014. Pediatric patients included which had indication for the insertion of a nasogastric tube (Edi catheter), independent of the study. So Edi catheter had been used instead of nasogastric tube.

When the patients were ready for clinical weaning in accordance with the clinician, the Edi catheter was appropriately inserted into the patients. Then, a spontaneous breathing trial (SBT) was performed and diaphragm activity monitoring was recorded during this process. The patients who met the inclusion criteria switched in a spontaneous breath trial with pressure support ventilation (PSV) or NAVA (Neurally Adjusted Ventilatory Assist) on a Maquet (Solna, Sweden) Servo-i mechanical ventilator for both ventilation modes The patients' demographic and clinical characteristics, mortality scoring, vital parameters (HR, TA, SpO2, RR) and ventilatory parameters (Edi peak, Edi min, FiO2, expiratory Vt), as well as follow-up period were recorded. Arterial/capillary blood gases were taken within the last four hours before extubation and within the first, sixth, 12th, 18th and 24th hours after extubation. If arterial blood gas monitoring was initiated in the patient, arterial monitoring was continued. If capillary blood gas monitoring was initiated, capillary monitoring was continued. Edi data were recorded for at least 24 hours before and after extubation. Edi values were obtained retrospectively from the trend diagram, which provides 24-hour continuous records on the ventilator screen.

• Study Type: Observational
• Enrollment (Actual): 25

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The majority of the patients were under 18 months of age (median 18 months, between 2 and 204 months) and 60% (n=15) were female.

Description

Inclusion Criteria:

• • Aged between one month and 18 years old

  • Intubated for more than 48 hours due to respiratory failure
  • Indication for the insertion of a nasogastric tube (Edi catheter), independent of the study

  • Ready for weaning:

    • Normal vital signs for age (fever, heart rate (HR), respiratory rate (RR), tension arterial (TA)
    • No catecholamines or sedation drugs
    • pH of 7.35 to 7.45
    • Positive end expiratory pressure (PEEP) ≤6 mmHg
    • Fractionated oxygen (FiO2) ≤0.5
    • Oxygen saturation (SpO2) ≥92%
    • Vt≥ 5 ml/kg

Exclusion Criteria:

• • Contraindication for the insertion of the nasogastric tube (Edi catheter)

  • Patients treated with muscle relaxants
  • Absence of consent given by the patient's family
  • Cases whose Edi levels could not be taken from ventilator's trend diagram due to missing values.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Extubation failure	Device: Edi catheter
Extubation success	Device: Edi catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diaphragm electrical activity (Edi) monitoring	Macquet (servo-i) mechanical ventilator measures the electrical activity (Edi) of the diaphragm (microvolts). Edi signals are measured using special feeding tubes (Edi catheter) equipped with tiny sensors at the level of gastroesophageal junction. In the ventilator, Edi trend values can be monitored continuously as 24-hour records.	up to 2 days
Mechanical ventilatory monitoring	ventilatory parameters (Edi peak, Edi min, FiO2), were recorded during the follow up.	up to 2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial/capillary blood gases	If arterial blood gas monitoring was initiated in the patient, arterial monitoring was continued. If capillary blood gas monitoring was initiated, capillary monitoring was continued.	Arterial/capillary blood gases were taken within the last four hours before extubation and within the first, sixth, 12th, 18th and 24th hours after extubation.
Vital signs ((fever, heart rate (HR), respiratory rate (RR), tension arterial))	Vital signs recorded by pediatric intensive care nurses.	up to 2 days
Expiratory tidal volume	Patients who had >5ml/kg expiratory tidal volume considered to be ready for extubation	From spontaneous breathing trial until the time for extubation

Collaborators and Investigators

• Sponsor: Mersin University
• Investigators: Study Director: Nilufer Yalindag-Ozturk, Proffessor, Marmara University Medical Faculty, Pediatric Intensive Care Speacilist

Publications and helpful links

General Publications

• Beck J, Sinderby C. Neurally Adjusted Ventilatory Assist in Newborns. Clin Perinatol. 2021 Dec;48(4):783-811. doi: 10.1016/j.clp.2021.07.007. Epub 2021 Oct 2.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): July 30, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Estimated): December 8, 2023

Study Record Updates

• Last Update Posted (Estimated): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pediatrics; extubation success; Diaphragm electrical activity
• Other Study ID Numbers: 1400124188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD, will be shared in publication study
• IPD Sharing Time Frame: 4 month
• IPD Sharing Access Criteria: After publication of study, the study will be shown by request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No